Category Archives: Quality

Gap Analysis – Creating a team

Gap Analysis is a technique companies use to compare their current performance with potential performance. For example, their current practices compared to an international standard such as ISO9001, AS9001, ISO14001, ISO13485 or customer requirements. A well-executed gap analysis can help you improve quality, business efficiency and fulfil the customer needs by allowing you to pinpoint ‘’gaps’’ within your company. It outlines what areas of your current Quality System needs improvement to meet the requirements. Therefore, you need to clearly define and analyze these ‘’gaps’’ so you can set-up an action plan to move the organization to a future state and fill the gaps in performance.

So where do you start? If you’re wondering this, I advise you to follow the next steps to move your company to a future state.

1.1 Identify

The first step to creating a successful gap analysis is to identify one or more employees to perform it. In this process, it is crucial to choose the right people to fulfill the tasks. Think of quality managers or other employees who have experience with quality management systems, auditing systems or the requirements of the standard/customers. The team must be familiar with the challenges and opportunities your company faces during this analysis. Also good communication skills are required to make sure the results are communicated properly throughout the organization. If your team has not been trained on the requirements, be sure to provide proper training before performing the gap analysis.

1.2 Consultancy

You may also want to consider having assistance from a consultant. You may decide to hire a consultant for several reasons. However, knowledge of the requirements is not the primary reason organizations tell us they have chosen to utilize consultants to upgrade their Quality System. The people in your organization have their own daily responsibilities. Therefore, additional work can have consequences for the quality that they deliver. Also, a fresh pair of outside eyes can have refreshing results. In this case, a consultant comes in handy, so that your employees can continue to focus on what they are really good at and use their valuable time productively. If the requirements are highly technical or require a specialist, we always recommend to find a professional with experience in that particular field.

1.3 Gap Analysis Checklist

A commonly used tool for the gap analysis is the gap analysis checklist. This is a checklist of the requirements in the standard, written in a question-based format. The implementation team will use this list to compare your current management system with the requirements of the standard. This will provide your team with the right information. They will know which documents to look for to compare your management system with the standard.

Next week we will discuss the following steps, and dive deeper into the important elements needed to successfully perform a gap analysis. Don’t forget to keep up-to-date with the latest quality and safety news and subscribe to our blog! Until next week!

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Operational Excellence, how to bring it in practice

No doubt you have heard of Operational Excellence. It is a managerial buzzword just like ‘agile’, but Operational Excellence is also something every company should strive to achieve. Running operations as effective as possible will help the company not only to make more money, but also to keep employees happy. When less things go wrong, less people will complain.

But what is operational excellence? Well according to Wikipedia, Operational Excellence means:

The execution of the business strategy more consistently and reliably than the competition.”

This sounds nice in theory, but how do we accomplish this in practice? Hardly any companies have the same strategy so comparing companies is pretty hard, except of course when we look at financial figures. That is why it is very important to have your own benchmark to work with.

The Fundament

An integrated management system is the backbone of Operational Excellence. The IMS will consist of the internal process and the forms that are used for the required checks and balances. With modern online SaaS solutions the IMS can be managed with the highest efficiency.

These platforms will be your backbone that holds all your information together and allows you to distribute this information among your employees. There is no need to track and trace everything by hand. The backbone is critical for getting the right information and for creating that benchmark.

The Importance of Data

Data is a key ingredient in operational excellence. To benchmark your performance, data is required to do this. The data needs to be easily accessible and searchable to find the right information in your IMS.

Online platforms are the best modern technologies to not only have access to the data, but also to gather the information. However, in the end someone within the company needs to key in the data, as it won’t be created in the Cloud.

These modern platforms allow for secure access the data to anywhere in the world. At the same time their mobile apps allows for data creation at every location, production site or manufacturing plant. This way quality and safety related data can be harvested right at the time when something happens. The ability to create the report right away increases the number of reports significantly, which leads to more data overall to analyze.

Operational Excellence

When all the data has been gathered, it can be analyzed to see how efficient the company really runs. To reach Operational Excellence the company has to set internal goals to see how the efficiency can be improved. Trend analysis are crucial to track improvements over time.

Internal dashboards should be created to communicate the results with the company. The modern online platforms come with a built-in Dashboard manager to display the data the way you’d like. Displaying this data to every employee is crucial to create awareness and support by the employees, which will lead to better results.

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How to Use Kaizen to Continuously Improve Your Business

Kaizen, or Kai Zen, is Japanese and stands for ‘continuous improvement’. This means: How can we improve / adjust our products and / or services so that the customer is satisfied and we stay ahead of the competition? Some of such changes require great efforts; which means months of hard work and dedication. But often undervalued is ‘Kaizen’ or the long-term approach to improving systems through small, sustained changes in processes in order to improve efficiency and quality.  

The Six Stages of Kaizen

Kaizen has six steps in the continuous improvement process. The focus is on mapping out waste, inflexibility and uncertainties within the process. A kaizen with the following six clear steps ensures lasting results and motivated employees.

1. Identify

Map out the process, look for information in flowcharts and other work instructions. Make sure to describe your goal as clearly as possible, so that misunderstandings can be prevented. After that ensure that your employees are well trained in the process. 

2. Measure

Collect data by looking at the management system. A well organized management system like Qooling can ensure that data can be easily retrieved, so you can effortlessly see what’s going on in your organization at any time. 

3. Analyze

Analyze the collected data by using the 5 Why & 2 How model. This tool forces you to really think about what went wrong and how to improve it. Learn more about this methodology here. 

4. Innovate

Search for new, better ways to do the same work or achieve the same results. Look for smarter, more efficient routes to get to the same goal that boosts productivity.

5. Standardize

After you have improved your process successfully, make sure that the changes are documented and made part of the clearly defined process, so that everyone using the process can benefit. 

6. Repeat

The circle of continuous improvement states that after completing the steps, you then repeat the cycle by making another small improvement. 

The Six-Step Problem-Solving Process is an easy approach to dealing with issues and problems that you face. It is a systematic way to approach a problem with clearly defined steps so that an individual or team always have a clear grip on the process. 

Need help? 

Wondering how Qooling can help with successfully implementing kaizen? Contact us for a free consultation with one of our experts. 

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How to Perform a Failure Mode Effects Analysis (FMEA) in 10 Easy Steps

History of the FMEA

The FMEA analysis is an common used Lean Six Sigma tool. In the past, the FMEA method was initially used by NASA in aerospace and for high-risk technologies. Since the 1980s, the tool has also been used in the automotive industry for Quality improvement. Nowadays the FMEA is a widely used tool for risk assessment & evaluation mainly in the manufacturing industry.

What is FMEA?

The Failure Mode and Effects Analysis (FMEA) is a structured approach for analyzing potential reliability problems at the start of the development cycle. The tool examines what can be done in the product process to ensure that appropriate measures can be taken to eliminate errors and prevent or reduce their impact. The 10 steps of the FMEA process are explained in a simple way below:

STEP 1: Review the Process

It is important to review the processes that are followed within the company. These processes can be stored in documents or maybe you make use of a dedicated solution for this such as Qooling. Then make a list of each process component in an FMEA table. Advanced QMS solutions allow you to connect the procedure directly to the FMEA table.

STEP 2: Brainstorm potential failures modes

Here you investigate what can go wrong. Therefore, study existing documentation and data which you summed up in the previous step. Identify all the ways in which the process can fail for each component. For example with Qooling you can easily assign the process to every potential failure mode.

STEP 3: List potential effects of each failures

Consider the possible failures and the effect these errors would have on the final product or the next steps in the process. It is important to think thoroughly about the potential effects because this allows you to develop some great solutions to prevent it from happening.

STEP 4: Assign a Severity Ranking for each failure mode

Give a ranking score for each effect. For example, a frequently used ranking is that 1 is not serious at all and 10 is extremely serious.

STEP 5: Assign Occurrence Ranking for each failure mode

Estimate the probability of occurrence of the cause. Also use a scale from 1 to 10 to  keep a clear picture of the severity of the causes. Where 10 signifies high frequency and 1 signifies low frequency.

STEP 6: Assign deception ranking for each failures mode or effect

What are the chances the failure will be detected prior to it occuring. Here a score of 1 would mean we have excellent control and 10 would mean we have no control or extremely weak control.

STEP 7: Calculate the RPN (Risk Priority Number) for each effect

To decide where to focus first, multiply the Severity, Occurrence and Detection scores together to find the RPN value.

STEP 8: Develop the action plan

During this step, you must prioritize which failures are processed first on the basis of the RPN scores.

STEP 9: Take action to eliminate or reduce high risk failures modes

Assign new tasks to the responsible person within your organisation. This can be collecting data, changing processes or products, adding or removing functions. A Task Management solutions makes is possible to manage those tasks in clear overviews. The responsible employee and management will receive email notifications whenever important changes are made. This makes it much easier to keep track of the progress.

STEP 10: Calculate the RPN again as the failures modes are reduced or eliminated

It is important to document the changes made to the process. Once the actions are complete, analyze the results. Determine whether the changes have helped and re-score the occurrence and detection. 

Making FMEA Easy

A Quality Management Software can help you understand your business processes so that you can identify problems at an early stage. By means of automated push notifications, the solution keeps you alert of changes in your product / development process. This allows you to quickly intervene and reduce the impact of the error. Qooling has a built-in template for FMEA risk evaluation. Contact us if you want to know more on how to use this.

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A3 Problem Solving Tool

An effective and simple approach for problem solving is Toyota’s famous (lean) A3-approach. This problem solving technique is a good example of how problems can be handled in order to be eliminated efficiently. The A3 lean method can be applied in almost any problematic situation, provided that all the steps in the process are completed.

1.   Define the problem (Plan)

To clearly identify the problem, it is important to investigate the underlying problem. A handy tool for identifying the problem is the Kipling Method (What, Where, Who and How) or the 5 Whys, so that you get deeper and deeper into the problem and its cause. In addition, you can also use an application like Qooling, that makes it easy to report problems as soon as they occur. This will save time and help you quickly identify the cause.

2.   Break down the problem (Plan)

Once you have found the current problem, it’s time to capture and analyze the current situation. Make sure all the information of the problem is known. Try to really get to the root cause of the problem and work out what happened by breaking it down into parts.

3.   Set a target (Plan)

Formulate a clear and achievable goal: When will the problem be solved? What is the result and the effect you want to achieve? By setting clear goals, the change to solve a problem successfully is many times greater than when it is not.

4.   Analyze the root cause (Plan)

Now that you have clearly defined your goal, it is time to carry out a root cause analysis. This will help you reach the underlying cause of the problem. Proper issue management solution will support root cause analysis.

5.   Develop countermeasures (Do)

Countermeasures are your ideas for solving the problem. These can be changes in your business processes that bring you closer to solving the root cause. Make sure you create actions to track progress of this phase. Qooling allows you to easily manage these tasks and track the progress.

6.   Implement countermeasures (Do)

Analyze whether the countermeasure introduced has the intended effect. Make sure you have the end results of the tasks searchable.

7.   Evaluate results and processes (Check)

In far too many situations, the A3 process ends with the implementation of the countermeasures. It is crucial to measure results and compare them with the goal you have set. If your actual results differ from what was expected, do an investigation to find out why. Analyze your data and and see how often the same problems occur.

8.   Share new knowledge with employees

Once the results are back, it is important to share your insights with other employees. Qooling makes it possible to easily collaborate online with colleagues and share knowledge through our online solution. This will keep everyone up-to-date and reduces the chance of making the same mistake again.

By implementing this process properly you should be able to get a good feel for the cost of failure and how you can reduce this.

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What Every Company Needs to Know About Valuable Safety Management

It doesn’t matter what industry you work in: prioritizing safety management is a crucial responsibility of any high-level manager. If protocols are not established, your business risks having staff injured on the job. As one workers compensation attorney in Philadelphia states: “Most victims are unable to continue working in the same capacity as before the injury.”

Injuries on the job due to improper management can be harmful to your bottom line. They can also deter clients and employees from seeking you out. But, successful safety management protects employees and ensures the organization is compliant with all relevant laws.

A strong safety management system can help companies achieve this crucial goal. However, before selecting one, it’s important to understand certain key points.

Identifying Risk Factors

An effective safety management system will gather important information about the potential risks your employees may be exposed to on the job. This system can track various types of information, like employee medical history and the kinds of safety hazards common to workers in your industry.

The gathered information makes it easier for you to identify what types of danger your workers are most likely to find themselves in. Thus, you’re better prepared to put preventative measures in place.

Handling Important Processes

A safety management system shouldn’t just help you identify hazards. It should also help you evaluate the performance of any steps you take to mitigate risks. You can, and should, use your system to regularly assess the impact of your safety efforts and programs.

No One Person is Responsible for Implementing the System

Don’t make the mistake of assuming that only dedicated safety specialists play a role in implementing and maintaining this system. Everyone in the company’s chain-of-command is involved.

A senior manager is likely to be the one who establishes protocols and allocates the necessary funds and resources for a safety management system. But, management is responsible for ensuring these protocols are maintained within their individual departments.

Safety Systems Boost Efficiency

According to a recent study, safety management systems are effective at reducing the frequency of accidents in the workplace. As OSHA points out, this results in a major boost in both productivity and efficiency.

Companies incur additional expenses when employees get hurt or sick on the job. The cost of investigating the accident, compensating the employee, and possibly having to hire and train a replacement can have a major impact on a company’s yield.

Safety management systems prevent these consequences. They’ve also been shown to improve employee morale, which further improves productivity.

Constant Improvement

Safety management systems evolve. By monitoring their effectiveness, managers can identify areas of the business that need improvement. Making sure lower-level employees can contribute feedback is a smart way to improve the system, as they are often more likely to be exposed to hazards. Additionally, employee feedback is one way to devote attention to continuous performance management and boost your organization’s morale and efficiency.

Improved Products

A safety management system is geared towards identifying and addressing hazards. That said, when used properly, it can also indirectly enhance the quality of a company’s products or services.

That’s because responding to workplace injuries depletes an organization’s resources. When employees are safer, a company can direct more attention and energy to optimizing its products. The company’s staff will also be more productive on the job. As a result, the entire business performs at a higher, more consistent level.

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Why data is important in Quality Management.

At the center of all quality management systems is the concept of continuous improvement. This implies that you have the ability to prove that there has been some kind of improvement. It may sound straightforward, but it isn’t always that easy to do. Many times there is limited data or even no data to even come up any results. In order to prove progress, it is important to have the consistent data to back it up.

Collecting Data

Data is a main ingredient to show how the company improves on certain KPI’s. However, collecting the data is more often that not a very labor intensive task, mainly done by the quality department. In order to make it easy for the organization to share the required data, it should be fairly easy for employees to do this. A mobile app helps in this process. Having all the important forms at your fingertips makes it so much easier to share this information, which allows the quality department to focus on analyzing the data instead of pushing people to provide it. Also having an open IT infrastructure which allows for sharing data between systems is key in order to pull the data from different sources.

Analysing Data

When the data is gathered it should be analyzed properly. This is not just drawing graphs but also interpreting the changes of the data over time. Different time frames could show interesting effects. Furthermore, mapping out different root causes will give more insight on how to improve the company. It is important to play around with the data and not only focus on the predefined KPI’s. Playing around and plotting different variables against each other can give completely new insights. A great technique to check out where this goes wrong is by using the “Pareto” plot of the data.

 Showing Results

Maybe the most important aspect of using data to improve quality management is communicating the results. Not only to top management, but to the employees within the company. Every employee helps by providing the data. When you involve them in the results of the analysis, they see the impact they had on the company instantly. Which then makes them more willing to share again in the future.

 Pitfalls

The biggest pitfall with analysis data is the inconsistency in the data. It is very important the data is clean and usable. This can be easily checked simply by plotting the data and looking for weird spikes. Also during the setup, it is required to predefine certain choices. When you give employees the option such as “I don’t know” or “general”, they will most likely choose that. This will lead to a lot of data with that option, which completely ruins the possibility to analyze it, so try to prevent these options.

 

Qooling makes collecting information and analyzing it a lot easier by a simple to use mobile app and the straightforward interface of its platform.

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How to apply the PDCA-cycle to improve your business!

The PDCA (plan-do-check-act) cycle is a four-step approach which is used in business for the control and continual improvement of processes and products. By consistently testing out possible solutions, comparing the results and implementing those that are successful, there is the potential for steady improvement in all areas. Therefore, the PDCA cycle fits exactly to the elements and requirements of the quality management system.

Planning

The PDCA cycle starts with planning, in which your problems or opportunities are identified and understood. Collect as much relevant data as possible and find the cause of the problem. The data can be collected from your recalls, quality issues, safety problems or any other register in which data is accumulated. After the data is gathered, it is important to make a plan according to the mission, vision and values of the company. This allows the company to stay close to what is important for it. Set goals and determine the best way to meet them.

Execution

In the ‘do’ phase, all planned activities of the process take place. Use the approved plan from the previous phase as a starting point. Set a clear goal that you want to achieve and measure the results along the way. Involve the employees while executing the plan – this helps with gaining trust and allows them to contribute to improving the company. It is crucial that data is collected to see what happens over a period of time.

Check

Once the data of the execution phase is collected, it is essential to make it understandable. When the data is known, it is important to benchmark this data against the data that was identified in the planning phase. The initial data was collected to spot certain areas to improve. Now check the new data against your initial goals while at the same time benchmarking it against the old data. According to the results, you can then go to the next step – act.

Act

On the basis of the analysis and results from the previous phases, decisions can be made on whether previous measures and plans need to be adjusted. If necessary, adjust the plan and start again with planning phase. When the results show no consequences, it is important to make the decision to stop the project. This will prevent the company from spending resources on projects which have a low likelihood of adding value.

How PDCA Is Covered in Qooling

Qooling allows for easy gathering of information throughout the company. This data can be used to identify improvement projects and plan ahead for them. During the execution phase you can assign tasks to employees and again allow them to share information fairly easily. The information can then be used to check the results and benchmark against the situation which occurred months ago. This way the results can be found by the a few simple clicks.

Conclusion

The PDCA-cycle is a great way to improve the operations, but similar to most management practices it is important to gather the data to check the progress. Gathering this information isn’t always easy or straightforward, so it is important to use the proper solutions to get accurate results.

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How management buy-in can help ISO implementation

One of the most difficult tasks that a person may need to undertake before approaching the ISO topic is to win the buy-in from top management. QHSE is considered a cost center where resources are spent to implement and manage the system, but the benefits may not be immediately apparent.

Of course, a key concern for top management is a healthy bottom-line. This is communicated to all department heads in the form of KPI’s with accountability. This means that everyone knows what is important for top management and what is expected of them. But this rarely happens when it comes to ISO.

Sending the right message to your people about the importance of cooperation with the implementation project means a smoother transition. Things get done in a more timely manner. With the right level of support, within six months you must be able to build a completely integrated management system across multiple locations and different business units.

Depending on the size and complexity of an organization, an ISO system contains multiple components. How quickly these are prepared and ready for use depends on the involvement of top management.

So what happens if the management doesn’t send the right message?

Not much attention is paid to ISO and the initial never gets off the ground, usually because the QA Manager leaves it to the departments. In this case, departments are so busy that they never manage to do their part. As a result, the term of 2 weeks changes in 1 month, then 2 months, etc.

Internal auditors are trained for a period of 2 days, but when audits are required, most trainees are not available. And if they are, they rush through the audits, missing crucial non-compliances.

There are challenges for your authority as an auditor. Non-conformities do not get addressed in a timely manner. Corrective and Preventive Actions don’t get adequately implemented or they are addressed in a rush to get you out of the way.

Requested data such as those for KPIs, HSE and customer feedback are never sent or you have to ask for it again and again.

There is a poor turnout at management assessments or safety committees.

These are the worst case scenarios, but not uncommon.

So how do you bring management on board?

  • Work out the Cost of Quality and that is not the cost involved in implementing and managing it.
  • Calculate the direct costs of not implementing health and safety, but also highlights the indirect costs of the more difficult to quantify, but are costs nonetheless.
  • Explain what QHSE would mean for their customers and future customers.
  • Explain how a QHSE system would improve their supplier relationships and business results

Because money is an important subject, it is important to emphasize that QHSE is not only a cost center, but also a profit center, provided that they become involved.

This article has been written by Birjees Hussain

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